Catalog Number

36-PSA1200

Brand Name

Micro Medical

Version/Model Number

36-PSA1200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

4890f490-4221-45c6-8870-ec466abaf51c

Public Version Date

March 23, 2020

Public Version Number

4

DI Record Publish Date

April 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-